The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Irrigation Tray.
Device ID | K944882 |
510k Number | K944882 |
Device Name: | IRRIGATION TRAY |
Classification | Tray, Irrigation, Sterile |
Applicant | CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
Contact | David Insco |
Correspondent | David Insco CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
Product Code | EYN |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-03 |
Decision Date | 1995-01-12 |